Huh. Who knew that there's a "formal dispute" proc
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Posted On: 11/04/2022 5:13:12 PM
Huh. Who knew that there's a "formal dispute" process to the FDA.
I assume that the FDA is in charge of the appeal. I bet THAT's not biased in favor of the FDA, not one bit.
I assume that the FDA is in charge of the appeal. I bet THAT's not biased in favor of the FDA, not one bit.
Quote:
Akebia Therapeutics has elected to not sit idly by after regulators rejected its chronic kidney disease med vadadustat earlier in the year, submitting a formal dispute request to the FDA.
In a complete response letter back in March, the agency had flagged safety concerns related to adjudicated blood clots and drug-induced liver injury. But Akebia pushed back last month, sending across a formal dispute request that defended vadadustat as a potential treatment for anemia due to chronic kidney disease in adult patients on dialysis.
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